The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate).
Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.
Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis | Drug: Bafiertam Drug: Tecfidera | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers |
Actual Study Start Date : | July 7, 2019 |
Actual Primary Completion Date : | October 19, 2019 |
Actual Study Completion Date : | October 19, 2019 |
Arm | Intervention/treatment |
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Experimental: Bafiertam
oral capsules administered twice daily
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Drug: Bafiertam
Over-encapsulated capsule to mask treatment
Other Name: monomethyl fumarate
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Active Comparator: Tecfidera
oral capsules administered twice daily
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Drug: Tecfidera
Over-encapsulated capsule to mask treatment
Other Name: dimethyl fumarate
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
BioPharma Services, Inc. | |
Columbia, Missouri, United States, 65201 |
Principal Investigator: | Kathleen Doisy, MD | BioPharma Services, Inc |
Tracking Information | |||||||||||
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First Submitted Date ICMJE | July 15, 2019 | ||||||||||
First Posted Date ICMJE | July 17, 2019 | ||||||||||
Last Update Posted Date | January 18, 2020 | ||||||||||
Actual Study Start Date ICMJE | July 7, 2019 | ||||||||||
Actual Primary Completion Date | October 19, 2019 (Final data collection date for primary outcome measure) | ||||||||||
Current Primary Outcome Measures ICMJE |
Area Under the Curve (AUC) in each of the individual symptoms over the treatment period. [ Time Frame: 5 weeks ] The symptoms measured are (1) nausea, (2) vomiting, (3) diarrhea, (4) upper abdominal pain, (5) lower abdominal pain, (6) constipation, (7) bloating, and (8) flatulence
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Original Primary Outcome Measures ICMJE |
Comparison of the Modified Overall Gastrointestinal Symptom Scale (MOGISS) composite score [ Time Frame: 5 weeks ] The daily mean of all 8 individual GI symptom scores over the treatment period
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Change History | |||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||
Descriptive Information | |||||||||||
Brief Title ICMJE | Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers | ||||||||||
Official Title ICMJE | A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers | ||||||||||
Brief Summary |
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate). Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects. |
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Detailed Description | Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks. | ||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis | ||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||
Recruitment Status ICMJE | Completed | ||||||||||
Actual Enrollment ICMJE |
210 | ||||||||||
Original Estimated Enrollment ICMJE |
200 | ||||||||||
Actual Study Completion Date ICMJE | October 19, 2019 | ||||||||||
Actual Primary Completion Date | October 19, 2019 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||
Listed Location Countries ICMJE | United States | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT04022473 | ||||||||||
Other Study ID Numbers ICMJE | BLS-11-109 | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Banner Life Sciences LLC | ||||||||||
Study Sponsor ICMJE | Banner Life Sciences LLC | ||||||||||
Collaborators ICMJE | Not Provided | ||||||||||
Investigators ICMJE |
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PRS Account | Banner Life Sciences LLC | ||||||||||
Verification Date | January 2020 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |